Quality Assurance Validation Specialist

Company: Unicon Pharma
Location: Boston
Posted on: November 23, 2020

Job Description:

Job Description: The individual will provide Quality Assurance oversight in support of a site project to remediate Data Integrity (DI) commitments. The individual will be responsible for the quality review and approval of validation and change control documentation such as protocols, test plans, various computer validation testing documents, deviations, and change controls in relation to DI remediation activities. The documentation will span the breadth of validation and change control requirements for biopharmaceutical processing therefore validation and quality assurance experience in an manufacturing GMP environment is required. The individual will also ensure that the execution of documents adheres to the governing SOPs, protocols, project plans, cGMP, etc. Upon completion of their review, the individual will also be responsible for the release of equipment back to GMP manufacturing. Responsibilities: Provide QA review of executed validation documents such as change controls, protocols and test plans, validation testing documents, and deviations. Ensure compliance to governing SOPs, validation plans, and protocols throughout the project. Release equipment back to GMP manufacturing as part of change control. Have the ability to independently assess impact and re-testing requirements in the event of a deviation. Interactions will primarily be between engineering/validation personnel. Some interaction will also occur with operation personnel, lab and Quality Control reps as applicable. Additional Skills: Proficient in reviewing executed validation documents (change controls, protocols and test plans, validation testing documents, deviations, etc.) Knowledge of cGMP regulations as they pertain to the pharmaceutical/biopharmaceutical industry. Thorough understanding of the computer validation lifecycle, including change control Identify and address any potential quality impact throughout the project Position will be office/desk based. Position is first-shift with potential for second shift coverage, on occasion. No travel from the site is required. Education: Bachelors Degree in engineering or life sciences 5 years of computer validation/QA experience in a GMP environment Experience with change control as a Quality Assurance approver 1 year of experience with Trackwise change control software (or similar)

Keywords: Unicon Pharma, Boston , Quality Assurance Validation Specialist, Other , Boston, Massachusetts